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    List of Drug Master Files (DMF) for 28951 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    MYLAN LABORATORIES LTD

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    DIFLUNISAL, USP

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    28951
    Active
    2015-01-12
    Complete
    2015-05-19
    2015-02-26
    II
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    Looking for Drug Master Files (DMF) for 28951 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 28951 of Mylan Laboratories Ltd 1

    20

    Mylan Laboratories Ltd, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is DIFLUNISAL, USP, with a corresponding US DMF Number 28951.

    Remarkably, this DMF maintains an Active status since its submission on January 12, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 19, 2015, and payment made on February 26, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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